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Noda K. et al have demonstrated that Irinotecan and cisplatin (IP) significantly improves survival compared with cisplatin and etoposide (EP) in patients with extensive stage SCLC (Pro ASCO, 483a, 2000). The use of Irinotecan for the treatment of limited-stage patients is not fully resolved. This pilot study evaluated the safety of sequential administration of IP to EP plus thoracic radiotherapy.

Materials and Methods

Eligible, patients had to have previously untreated LD-SCLC, be less than 75 years old, ECOG performance status (PS) 0-2 and adequate organ functions

31 patients were enrolled onto the study from October 1999 through July 2000

There were 27 male, 4 female patients

Median age 62, range 43-74, PS 0/1: 8/23.

The treatment consisted of 80 mg/m2 of cisplatin on day 1 and 100 mg/m2 of etoposide on days 1, 2 and 3. Accelerated twice-daily TRT started on day 2 and involved the administration of 1.5 Gy in 30 treatments over a period of 3 weeks.

After completion of PE/TRT, the patients received 3 cycles of IP started on day 29 and cisplatin on day 1 every 4 weeks

Results

30 patients received the protocol treatment, 11 patients had a complete response, 18 had a partial response, and one had progression of disease on treatment

The overall response rate was 97%.

The one year survival rate was 79.3% for patients who received the protocol treatment. Median survival has not been reached.

Author's Conclusions

The use of etoposide and cisplatin plus concurrent twice-daily TRT followed by 3 cycles of Irinotecan and cisplatin is a safe and active regimen with an encouraging one-year survival rate. JCOG has plans to conduct a phase III study of this regimen.

Clinical/Scientific Implications

Despite initial good response rates with conventional chemotherapy and radiation in limited- stage small cell lung cancer, most patients experience relapse within 2 years and die with disseminated malignancy. Improvements in both local control and metastatic disease are required, but it is likely that any substantial improvement or increases in cure rate will be secondary to the development of more effective systemic treatment. This small pilot study from the JCOG has yielded encouraging results.
A phase III trial evaluating this regimen against the current standard of care is indicated.